CN101022831A - 稳定制剂 - Google Patents

稳定制剂 Download PDF

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Publication number
CN101022831A
CN101022831A CNA2005800274833A CN200580027483A CN101022831A CN 101022831 A CN101022831 A CN 101022831A CN A2005800274833 A CNA2005800274833 A CN A2005800274833A CN 200580027483 A CN200580027483 A CN 200580027483A CN 101022831 A CN101022831 A CN 101022831A
Authority
CN
China
Prior art keywords
protein
formulation
molecular weight
antibody
stability
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CNA2005800274833A
Other languages
English (en)
Chinese (zh)
Inventor
L·李
A·坎托尔
S·B·麦米兰
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Wyeth LLC
Original Assignee
Wyeth LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Wyeth LLC filed Critical Wyeth LLC
Publication of CN101022831A publication Critical patent/CN101022831A/zh
Pending legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Cell Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
CNA2005800274833A 2004-08-13 2005-08-12 稳定制剂 Pending CN101022831A (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US60131104P 2004-08-13 2004-08-13
US60/601,311 2004-08-13

Publications (1)

Publication Number Publication Date
CN101022831A true CN101022831A (zh) 2007-08-22

Family

ID=35908214

Family Applications (1)

Application Number Title Priority Date Filing Date
CNA2005800274833A Pending CN101022831A (zh) 2004-08-13 2005-08-12 稳定制剂

Country Status (18)

Country Link
US (1) US8871201B2 (https=)
EP (1) EP1784219B1 (https=)
JP (1) JP4948407B2 (https=)
KR (1) KR20070092197A (https=)
CN (1) CN101022831A (https=)
AR (1) AR051009A1 (https=)
AU (1) AU2005272603A1 (https=)
BR (1) BRPI0514340A (https=)
CA (1) CA2575870A1 (https=)
CR (1) CR8904A (https=)
EC (1) ECSP077246A (https=)
ES (1) ES2637854T3 (https=)
IL (1) IL181265A0 (https=)
MX (1) MX2007001599A (https=)
NO (1) NO20070930L (https=)
RU (1) RU2007109062A (https=)
TW (1) TW200621282A (https=)
WO (1) WO2006020935A2 (https=)

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CN109661577A (zh) * 2016-08-18 2019-04-19 瑞泽恩制药公司 使用浓度相关的自相互作用纳米粒子光谱法确定蛋白质自缔合的可能性的测定
CN112986576A (zh) * 2014-07-21 2021-06-18 非链实验室 从δg的浓度依赖性来测定蛋白质聚集
CN115541895A (zh) * 2022-11-29 2022-12-30 天津德祥生物技术股份有限公司 一种提高微流控反定检测卡灵敏度的配方液及应用

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BRPI0611901A2 (pt) 2005-06-14 2012-08-28 Amgen, Inc composição, liofilizado, kit, e, processo para preparar uma composição
AU2007240732B2 (en) * 2006-04-21 2013-07-04 Amgen, Inc. Buffering agents for biopharmaceutical formulations
AR060487A1 (es) 2006-04-21 2008-06-18 Xoma Technology Ltd Composiciones farmaceuticas de antagonistas del anticuerpo anti- cd40
US20080070230A1 (en) * 2006-06-12 2008-03-20 Wyeth Methods for reducing or preventing liquid-liquid phase separation in high concentration protein solutions
EP1950225A1 (de) * 2007-01-25 2008-07-30 Octapharma AG Verfahren zur Steigerung von Proteinausbeuten
RU2476442C2 (ru) 2007-03-29 2013-02-27 Эббот Лэборетриз Кристаллические антитела против il-12 человека
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
US8420081B2 (en) * 2007-11-30 2013-04-16 Abbvie, Inc. Antibody formulations and methods of making same
RU2011126338A (ru) * 2008-11-28 2013-01-10 Эбботт Лэборетриз Стабильные композиции антител и способы их стабилизации
US10005830B2 (en) 2009-03-05 2018-06-26 Ablynx N.V. Antigen binding dimer-complexes, methods of making/avoiding and uses thereof
US9265834B2 (en) 2009-03-05 2016-02-23 Ablynx N.V. Stable formulations of polypeptides and uses thereof
US20100278822A1 (en) * 2009-05-04 2010-11-04 Abbott Biotechnology, Ltd. Stable high protein concentration formulations of human anti-tnf-alpha-antibodies
LT2805731T (lt) 2009-09-03 2019-02-11 Ablynx N.V. Stabilios polipeptidų kompozicijos ir jų panaudojimas
CN103930124B (zh) 2011-07-01 2021-05-11 生物基因Ma公司 无精氨酸的tnfr：fc-融合多肽组合物及使用方法
KR102143482B1 (ko) 2011-11-30 2020-08-11 쓰리엠 이노베이티브 프로퍼티즈 컴파니 펩티드 치료제 및 아미노산을 포함하는 마이크로니들 장치, 이의 제조 및 사용 방법
EP4527855A3 (en) * 2012-03-26 2025-06-11 Sanofi Stable igg4 based binding agent formulations
US9592289B2 (en) 2012-03-26 2017-03-14 Sanofi Stable IgG4 based binding agent formulations
US8883979B2 (en) 2012-08-31 2014-11-11 Bayer Healthcare Llc Anti-prolactin receptor antibody formulations
US9844594B2 (en) * 2012-12-18 2017-12-19 Merck Sharp & Dohme Corp. Liquid formulations for an anti-TNF α antibody
JP2016540826A (ja) 2013-11-04 2016-12-28 ファイザー・インク 抗ｅｆｎａ４抗体−薬物コンジュゲート
ES3055185T3 (en) 2014-03-28 2026-02-10 Univ Duke Treatment of an estrogen receptor positive breast cancer using a selective estrogen receptor modulator
GB201412658D0 (en) 2014-07-16 2014-08-27 Ucb Biopharma Sprl Molecules
KR20250152679A (ko) 2015-04-29 2025-10-23 래디어스 파마슈티컬스, 인코포레이티드 암을 치료하는 방법
GB201601073D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibodies
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PT3528787T (pt) 2016-10-21 2026-03-11 Amgen Inc Formulações farmacêuticas e métodos para produzir as mesmas
JP7481115B2 (ja) 2017-01-05 2024-05-10 ラジウス ファーマシューティカルズ，インコーポレイテッド Ｒａｄ１９０１－２ｈｃｌの多形性形態
MX2020013713A (es) 2018-07-04 2021-03-02 Radius Pharmaceuticals Inc Formas polimorficas de rad1901-2hcl.
EP3924328A1 (en) 2019-02-12 2021-12-22 Radius Pharmaceuticals, Inc. Processes and compounds
AU2021262609A1 (en) * 2020-05-01 2022-12-22 Kashiv Biosciences, Llc An improved process of purification of protein
KR20230131212A (ko) * 2021-01-14 2023-09-12 한올바이오파마주식회사 안정화제를 사용하지 않고도 안정한, 탄파너셉트를포함하는 안과용 조성물

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WO2001047554A1 (fr) * 1999-12-28 2001-07-05 Chugai Seiyaku Kabushiki Kaisha Compositions d'anticorps stables et preparations pour injection
JP5485489B2 (ja) 2000-08-11 2014-05-07 中外製薬株式会社 抗体含有安定化製剤
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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112986576A (zh) * 2014-07-21 2021-06-18 非链实验室 从δg的浓度依赖性来测定蛋白质聚集
CN109661577A (zh) * 2016-08-18 2019-04-19 瑞泽恩制药公司 使用浓度相关的自相互作用纳米粒子光谱法确定蛋白质自缔合的可能性的测定
US11428695B2 (en) 2016-08-18 2022-08-30 Regeneron Pharmaceuticals, Inc. Concentration-dependent self-interaction assay
CN109661577B (zh) * 2016-08-18 2022-09-27 瑞泽恩制药公司 使用浓度相关的自相互作用纳米粒子光谱法确定蛋白质自缔合的可能性的测定
US11988668B2 (en) 2016-08-18 2024-05-21 Regeneron Pharmaceuticals, Inc. Concentration-dependent self-interaction assay
CN115541895A (zh) * 2022-11-29 2022-12-30 天津德祥生物技术股份有限公司 一种提高微流控反定检测卡灵敏度的配方液及应用

Also Published As

Publication number Publication date
AU2005272603A1 (en) 2006-02-23
BRPI0514340A (pt) 2008-06-10
WO2006020935A3 (en) 2007-03-08
WO2006020935A2 (en) 2006-02-23
MX2007001599A (es) 2007-04-10
US8871201B2 (en) 2014-10-28
EP1784219A4 (en) 2010-02-17
EP1784219A2 (en) 2007-05-16
RU2007109062A (ru) 2008-09-20
IL181265A0 (en) 2007-07-04
EP1784219B1 (en) 2017-05-17
NO20070930L (no) 2007-05-14
CR8904A (es) 2007-08-28
CA2575870A1 (en) 2006-02-23
ECSP077246A (es) 2007-05-30
TW200621282A (en) 2006-07-01
JP4948407B2 (ja) 2012-06-06
JP2008515775A (ja) 2008-05-15
KR20070092197A (ko) 2007-09-12
ES2637854T3 (es) 2017-10-17
AR051009A1 (es) 2006-12-13
US20060115472A1 (en) 2006-06-01

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Open date: 20070822